The Therapeutic Goods Administration (TGA) recently released the Consumer Medicine Information (CMI) summary for the Pfizer COMIRNATY COVID-19 vaccine. The CMI summary starts by stating that “this vaccine is new or is being used differently”. The Pfizer vaccine uses mRNA technology, which has never been used in human beings previously. This would render it as “new”. What is concerning, however, is that the CMI states that it is being used “differently”. What exactly does this mean, and how is it being used differently? Health Minister Greg Hunt stated in a recent interview that the “world is engaged in the largest clinical trial, the largest global vaccination trial ever”. Is this what they mean by being used “differently”? Do they mean that anyone who receives the vaccine prior to January 2023, which is the estimated completion date for the Pfizer clinical trial, will be a human guinea pig? We certainly deserve an explanation as to how the vaccine is being used differently.
The CMI summary continues by stating that “this approval has been granted on the basis of short term safety and efficacy data. Evidence of longer term efficacy and safety from ongoing clinical trials and vaccination in the community continues to be gathered and assessed.” As mentioned previously, the Pfizer clinical trial is due for completion in January 2023. In his interview, Greg Hunt outlined that “above all else, safety, safety, safety” was the government’s primary concern, as it should be. We have heard many prominent government officials, include Prime Minister Scott Morrison, categorically state that the vaccine is effective and safe. How can one say that the vaccine is safe, without long-term safety data? The vaccine may well be safe in the short term, but we have no long term data to definitely classify it as safe. Ruud Dobber, a member of (AstraZeneca’s) senior executive team, stated that “this is a unique situation where we as a company simply cannot take the risk if in… four years the vaccine is showing side effects”. Although this is a different vaccine, it has also been provisionally approved by the Therapeutic Goods Administration, and has a similar lack of data compared to the Pfizer vaccine. If the vaccine is showing side effects in four years, will the government then deem it unsafe? It will be too late by then, and the damage would have already been done.
Under the heading “Why am I being given COMIRNATY?”, the CMI states that “COMIRNATY is a vaccine given to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults and adolescents from 16 years of age and older… COMIRNATY works by triggering your immune system to produce antibodies and blood cells that work against the virus, to protect against COVID-19 disease.” This is in direct contrast to the TGA’s Australian Public Assessment Report, which states that a “correlate of protection has yet to be established. The vaccine immunogenicity cannot be considered and used as a surrogate for vaccine protective efficacy at this stage.” The TGA is a government organisation that has produced the Australian Public Assessment Report and the Consumer Medicine Information. One report states that the Pfizer vaccine does not provide protection, yet the other one says that it does. In fact, the Pfizer clinical trials “specify that they do not even test for immunity”. This would indicate that the vaccine does not provide immunity, and that the TGA and the Australian government are misleading the Australian public.
Following this, the CMI states that “you should not be given COMIRNATY if you have had an allergic reaction to any of the ingredients in COMIRNATY”. One of the ingredients in the vaccine is polyethylene glycol (PEG), which is used to transport mRNA into the cell. It is estimated that up to 70% of Americans are allergic to PEG. How would someone know if they are allergic to PEG, given that most people would never have heard of it? Should we all get tested before we receive the vaccine to assess for an allergy to PEG? There have been a number of severe allergic reactions to the vaccine around the world, and it would appear that PEG is the culprit. No studies have been done on this, despite our repeated calls for such studies prior to the roll out of the vaccine.
According to the CMI, you should check with your doctor if you have had “a severe allergic reaction or breathing problems after any other vaccine or after being given COMIRNATY in the past, fainted following any needle injection, a severe illness or infection with high fever, a weakened immune system or are on a medicine that affects your immune system, a bleeding disorder, bruise easily or are on a blood thinning medicine”. The Australian Public Assessment Report states that the following information is missing: “Use in immunocompromised patients… Use in frail patients with co-morbidities (for example, COPD, diabetes, chronic neurological disease, cardiovascular disease)… Use in patients with autoimmune or inflammatory disorders… Interactions with other vaccines”. There is absolutely no data on these groups of people. Should people that fall into these categories be advised not to take the vaccine until further data is collected? What will the side effects be for these people? Where is the short and long-term safety data? This is highly dangerous, incredibly unethical and medically negligent.
The CMI initially stated that the vaccine will be administered to “protect against COVID-19 disease”. Further into the summary, it now states that “as with any vaccine, COMIRNATY may not fully protect all those who receive it and it is not known how long you will be protected”. Does it protect us or not? Now the CMI is contradicting itself.
Furthermore, the CMI summary explains that you must “talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.” The Australian Public Assessment Report clearly states that the “use in pregnancy and while breast feeding” is also considered “missing information”. In the UK, those that are planning to conceived within two months, those who are pregnant, or lactating mothers are advised not to have the vaccine. However, Health Minister Greg Hunt has stated that “for women who are considering being pregnant, they should feel free to take the vaccine”. There is no data on this group of women. COVID-19 has affected such a miniscule minority of pregnant women worldwide, that the risk of taking the vaccine outweighs the risk of developing COVID-19 during pregnancy.
“Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect, or are affected by, COMIRNATY.” The Australian Product Information states that “no interaction studies have been performed” when it comes to interactions with other medicines. Once again, how can the Australian government, the TGA, the Prime Minister and the Health Minister claim that this vaccine is safe when these studies have yet to be conducted? A large portion of the Australian population take some form of medication, and many of these people have co-morbidities. These vital studies need to be conducted before you can label this vaccine as safe.
Finally, the CMI summary states that “other side effects not listed here may occur in some people”. Other side effects? What are the other side effects? Are they mild or severe side effects? Are they short or long term side effects? Are they neurological or cardiovascular? We simply don’t know as they are not listed. Informed consent requires that all known side effects be made available to the patient, so that they can make an informed decision on the benefits versus the risks prior to consenting to treatment. This is clearly not being done as it should be, and is a gross breach of best medical practices.
It is time that the Australian government came clean and owned up to their lies and deception. The vaccine may be proven to be safe, however, one cannot definitively state that it is currently safe with so much data unavailable. It is little wonder that more and more Australians are refusing the COVID-19 vaccine. We have the right to decide what we inject into our bodies and the bodies of our children. The government do not have the right to coerce or manipulate people into taking an unproven and experimental vaccine.
Medical freedom is one of our basic human rights, and where there is risk, there must be choice.
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